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Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical) (PREVAIL-TA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01238835
First received: January 26, 2010
Last updated: February 7, 2017
Last verified: February 2017

January 26, 2010
February 7, 2017
September 2009
February 2011   (Final data collection date for primary outcome measure)
Freedom from death [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT01238835 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: 5 years ]

    Freedom from:

    • stroke
    • myocardial infarction
    • valve/device related reintervention/reoperation
    • access related complications
    • valve embolization
    • conduction defects requiring permanent pacemaker
  • Efficacy parameters [ Time Frame: 5 years ]
    • NYHA
    • 6 Minute Walk Test
    • Echocardiographic variables like effective orifice area, peak and mean gradient, aortic insufficiency and perivalvular leak
Same as current
Not Provided
Not Provided
 
Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical)
Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.

Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components.

Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Aortic Valve Stenosis
Device: SAPIEN XT™ Transapical aortic valve replacement
Transcatheter aortic valve implantation via the transapical approach
Other Names:
  • Sapien XT
  • Next generation Ascendra delivery system inclusive accessory
Experimental: TAVR-TA
Transcatheter valve replacement with transapical access
Intervention: Device: SAPIEN XT™ Transapical aortic valve replacement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
March 2016
February 2011   (Final data collection date for primary outcome measure)

Inclusion:

  1. EuroSCORE of ≥ 15 %
  2. Severe senile degenerative aortic valve stenosis
  3. Symptomatic aortic valve stenosis
  4. Informed consent
  5. Compliance

Exclusion:

  1. Logistic Euroscore > 40 %
  2. Evidence of an acute myocardial infarction
  3. Congenital unicuspid or congenital bicuspid valve/ non-calcified
  4. Mixed aortic valve disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   United Kingdom
 
 
NCT01238835
2009-06
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
No
Not Provided
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Prof. Dr. Thomas Walther Kerckhoff Klinik
Principal Investigator: Dr. Olaf Wendler King's College London
Edwards Lifesciences
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP